Att 7_Project Determination

12/18/2015

REQUEST FOR NCHHSTP PROJECT DETERMINATION & APPROVAL
NCHHSTP ADS/ADLS Office on behalf of CDC (New, Continuation, or Amendment)

This form should be used to request NCHHSTP/OD/ADS or ADLS office review and approval on behalf of
CDC of a new, continued, or amended project for those projects for which NCHHSTP staff/employees,
branches, divisions, and center/OD/ADS or ADLS office are responsible.
Any NCHHSTP activity that meets the definition of a project (see the following section) and represents
one of the four project categories must be approved by the respective NCHHSTP branch and division and
by the NCHHSTP/OD/ADS or ADLS office. Approval by the NCHHSTP ADS or ADLS office
(nchstphs@cdc.gov) of these projects indicates approval by CDC. This review and approval process
complies with obligations for adherence of projects to federal regulations, state laws, ethics guidelines,
CDC policies, and publication requirements.
For research that involves identifiable human subjects in which CDC/NCHHSTP is engaged, use CDC
Human Research Protection Office forms and submit them to CDC Human Research Protection Office
through the NCHHSTP ADS human subjects email box after approval at the branch and division levels.

RELEVANT INFORMATION
What is a project?
A project is defined as a time-limited activity that is funded for a specific period of time, an activity with
specified funds for a limited time, or as a limited time responsibility by specific CDC employees or staff,
including projects that might be ongoing or continuous for an extended period. A project has defined
objectives, tasks (e.g., essential public health services), dedicated resources, and is funded for a specified
time. NCHHSTP reviews and approves projects for the four project categories listed on this form. Every
project officer, project team and staff, NCHHSTP branch, and NCHHSTP division or office is responsible
for submitting this form for each project and for obtaining NCHHSTP OD/ADS or ADLS approval on behalf
of CDC before project initiation, continuation, or amendment. Such programs as surveillance are
approved and funded as specific projects for certain periods.

What is research?
The federal regulations and CDC/OD/ADS office define research as a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute to generalizable
knowledge. Activities that meet this definition constitute research, regardless if these activities are
conducted or supported under a program that is not considered research for other purposes. For
example, demonstration and service programs sometimes include research activities.

What is a human subject?
A human subject is a living individual about whom an investigator (whether professional or student)
conducting research obtains
1. data through intervention or interaction with the individual or
2. identifiable private information.

What is an intervention?
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
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What is private information?
Private information includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is occurring and information that has been
provided for specific purposes by an individual and that the individual can reasonably expect will not be
made public (e.g., a medical record). Private information identifies individuals (i.e., the identity of the
person is or might be readily ascertained by the investigator or associated with the information) for the
information to constitute research involving human subjects.

What does being “engaged” mean?
An institution becomes “engaged" in human subjects research when its employees or agents intervene
or interact with living individuals for research purposes, or obtains individually identifiable private
information for research purposes. An institution is automatically considered to be engaged in human
subjects research whenever it receives funding or resources (e.g., a direct award) to support such
research. In such cases, the awardee institution has the ultimate responsibility for protecting human
subjects under the award.

What is surveillance?
CDC defines surveillance as “the ongoing, systematic collection, analysis, and interpretation of health
data essential to the planning, implementation, and evaluation of public health practice, closely
integrated with the timely dissemination of these data to those who need to know. The final link of the
surveillance chain is the application of these data to prevention and control. A surveillance system
includes a functional capacity for data collection, analysis, and dissemination linked to public health
programs.”

What is program evaluation?
Program evaluation is the systematic collection of information about the activities, characteristics, and
outcomes of programs to make judgments about the program, improve program effectiveness, or inform
or guide decisions about future program development. Program evaluation should not be confused with
treatment efficacy, which measures how well a treatment achieves its goals and that can be considered
research.

Sources (links)
 http://intranet.cdc.gov/od/oads/osi/hrpo/
 http://www.hhs.gov/ohrp/index.html

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PROJECT REQUEST
Project Stage
Choose one by selecting a checkbox:
■

New: Fill out entire form, even if a protocol is attached (approval is for work by CDC/NCHHSTP employees).
Continuation: For projects expected to continue beyond NCHHSTP approved date; include brief description
of changes and attach clean and marked copies of approved determination (approval is for continued work
by CDC/NCHHSTP employees).
Amendment: Include brief description of changes and attach relevant documentation and a copy of
approved project (approval is for continued work by CDC/NCHHSTP employees).

Project Information:
Project Title: Project Engage 2.0: Engaging Gay Community Activism for Syphilis Prevention
NCHHSTP Project Number: 7105

Division: DSTDP

Project Location/Country(ies):
New Orleans, LA and Washington, DC USA

Telephone: (404) 639-2275

CDC Project Officer or CDC Co-Leads:

Monique Carry

Project Dates:
Start 05/01/2018
End 12/31/2018
Laboratory Branch Submission:
If applicable, select the checkbox:

Project Categories
Select the corresponding checkbox to choose the category and subcategory.
I. Activity is not human subject research. The primary intent of the project is public health practice or a disease
control activity.
A. Epidemic or endemic disease control activity; collected data directly relate to disease control. If this
project is an Epi-AID; provide the Epi-AID number and documentation of the request for assistance,
per division policy. Epi-AID no.
B. Routine disease surveillance activity; data will be used for disease control program or policy
purposes.
C. Program evaluation activity; data will be used primarily for that purpose.
D. Post-marketing surveillance of effectiveness or adverse effects of a new regimen, drug, vaccine, or
device.
E. Laboratory proficiency testing.
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II. Activity is not human subjects research. The primary intent is public health program activities.
A. Public health program activity (e.g., service delivery; health education programs; social marketing
campaigns; program monitoring; electronic database construction or support; development of patient
registries; needs assessments; and demonstration projects to assess organizational needs, management,
and human resource requirements for implementation).
B. Activity is purely administrative (e.g., purchase orders or contracts for services or equipment).
III. Activity is research but does NOT involve identifiable human subjects.
A. Activity is research involving collection or analysis of data about health facilities or other
organizations or units (i.e., not individual persons.)
B. Activity is research involving data or specimens from deceased persons.
C. Activity is research using unlinked or anonymous data or specimens: ALL (1–4) below are required:
1. No one has contact with human subjects in this project; and
2. Data or specimens are or were collected for another purpose; and
3. No extra data or specimens are or were collected for this project; and
4. Identifying information was (one of the following boxes must be checked)
a. not obtained;
b. removed before this submission, or before CDC receipt, so that data cannot be linked
or re-linked with identifiable human subjects; or
c. protected through an agreement (i.e., CDC investigators and the holder of the key
linking the data to identifiable human subjects enter into an agreement prohibiting
the release of the key to the investigators under any circumstances. A copy of the
agreement must be attached.)
■

IV. Activity is research involving human subjects, but CDC involvement does not constitute “engagement in
human subject research.” Select only one option by checking the box: A indicates the project has current
funding; B or C indicates no current funding is applicable.
■

A. This project is funded under a grant, cooperative agreement, or contract award mechanism. ALL of
the following 3 elements are required:
■

1. CDC staff will not intervene or interact with living individuals for research purposes.

■

2. CDC staff will not obtain individually identifiable private information.

■

3. Supported institution(s) must have a Federalwide Assurance (FWA), and the project must be
reviewed and approved by a registered IRB or an institutional office linked to the
supported institution’s FWA.*
Supported institution of primary investigator or co-Investigators/entity name:*
National Network of Public Health Institutes/Michigan Public Health Institute
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Supported institution/entity FWA Number:* FWA00000277
FWA expiration date:* 02/21/2019
Expiration date of IRB approval:* 04/13/2019
*Attach copy of IRB approval letter(s) supporting project review and approval.
B. CDC staff provide technical support that does not involve possession or analysis of data or interaction
with participants from whom data are being collected (no current CDC funding).
C. CDC staff are involved only in manuscript writing for a project that has closed. For the project, CDC
staff did not interact with participants and were not involved with data collection (no current CDC
funding).

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Project Description
Participating project staff must complete all 18 elements of this section.
This is a required description from CDC employees or staff for review and approval of a project plan or
proposal (or for changes) for projects conducted by CDC or in which CDC is involved. All 18 elements
are required to standardize the review and approval process across NCHHSTP, document that all 18
elements have been addressed, expedite review and approval by the NCHHSTP ADS or ADLS office, and
minimize CDC/OD/ADS office audit requests for additional information. A protocol may be attached to
this form, but it does not eliminate the requirement to complete all 18 elements.
PROJECT TITLE: Project Engage 2.0: Engaging Gay Community Activism for Syphilis Prevention

Instructions: Use the following boxes to complete the 18 items. Each box will expand as you type, and you are not
limited in the length of your answers. Formatting features and symbols also may be used.
1. CDC Principal Investigator(s) or Project Directors and branch/division/office affiliations:
Monique Carry, PhD
Community Assessment and Engagement Team
Social and Behavioral Research and Evaluation Branch
Division of STD Prevention

2. CDC Project Officer(s) and each person’s role and responsibilities and affiliations:
Randall H. Nielson
Umbrella Cooperative Agreement CDC-RFA-OT13-1302
Partnership Support Unit (PSU), Office for State, Tribal, Local & Territorial Support (OSTLTS)
Centers for Disease Control and Prevention (CDC)
Office: 770-488-1602
Cell: 404-274-8204
Fax: 770-488-1600

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
National Network of Public Health Institutes:
1100 Poydras St., Suite 950
New Orleans, LA 70163
Aaron Alford, PhD, Principal Investigator
Brittany Bickford, MPH, Project Manager
4. Institution(s) or other entity(ies) funding the project:
CDC via OSTLTS Umbrella Cooperative Agreement CDC-RFA-OT13-1302

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5. Project goals:

In this study, we intend to explore findings from the first iteration of Project Engage (which took
place from September 2016 to December 2017) and their implications for sexual health
community engagement and mobilization efforts. Specifically, we will explore the concept of
community belongingness, syphilis and PrEP knowledge, awareness, and opportunities, and
differences between the black/African gay community and the larger gay community.
6. Project objectives:
To inform the development of strategies to prevent and reduce syphilis transmission and
promote sexual health among Black/African American MSM

7. Public health (program or research) needs to be addressed:
Syphilis rates have increased dramatically in the United States since 2000, with most of the increases among MSM. In 2015, over 88% of
primary and secondary syphilis cases occurred among men, with over half of cases among males reporting a male sex partner (CDC 2016).
Untreated syphilis can lead to serious sequelae, including neurosyphilis, which has increased in recent years. Cases of ocular syphilis, which can
lead to permanent blindness, have been reported among MSM in recent months (CDC 2016). The reasons for syphilis increases among MSM
are not entirely clear; however, sex without condoms, sero‐sorting among HIV positive men, and the perception among some men that syphilis is
relatively benign and easily cured, are factors. The increased availability and use of PrEP (pre‐exposure prophylaxis), which protects against HIV
transmission but not STDs, further increases the need for STD programs to devise new and effective strategies for engaging MSM in STD
prevention efforts. The findings from this project will help ensure the relevance of prevention efforts, including but not limited to influencing
dissemination strategies and identifying appropriate content.

8. Population(s) or groups to be included:
Black/African American MSM in New Orleans and Washington DC

9. Project methods:
We will conduct in-person focus groups. We will follow a qualitative research design that
includes purposive sampling. This focus will allow for responsiveness to the specific research
objectives. Qualitative methods will allow participants to share their perceptions and opinions in
their own words. This approach allows for the investigation of potential reasons and the
mechanisms, beyond simple associations.

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10. Selection, inclusion, or sampling of participants (persons or entities):
We plan to conduct eight (n=8), 90-minute in-person focus groups with Black/African-American
men who have sex with men (MSM) age 18+ in New Orleans, LA and Washington, DC (four focus
groups per city). The participant pool will be stratified by age, falling into one of two groups: 18-34
(n=2 per city), and 35 and older (n=2 per city). Each focus group will have a max of eight (n=8)
participants, for a maximum total of n=64 participants across both cities.

11. Incentives to be provided to participants:

NNPHI staff will provide all forty participants a $50 Visa gift card as a token of appreciation for
completing the in-person focus group.
.

12. Plans for data collection and analysis:
NNPHI will work with local partner the Institute for Public Health Innovation, IPHI, in Washington, DC and hire an intern with evaluation experience as well as significant experience working with MSM to facilitate recruitment in New Orleans, LA. We anticipate recruiting
potential participants through a variety of community venues in both jurisdictions, using both active (i.e., venue outreach) and passive (i.e., referral, flyers/hand cards) recruitment techniques. Examples of community venues to be used for both active and passive
recruitment of participants will include local bars, clubs, university/college groups, house/ballroom communities, faith-based centers, community organizations and social events where black/African American MSM are known to congregate as well as virtual internet-based
venues such as social media and/or sexual networking websites or mobile apps, if necessary. Prior to beginning the in-person focus groups, NNPHI staff will read the consent form script and document verbal consent by assigning the consent form with the given participant
name for study record. This consent will address in more detail the potential benefits and address the potential risks of participation, such as a breach of privacy. As part of the verbal consent process, the interviewer will ask each participant if they have a clear
understanding of the study, its purpose, risks, benefits, and right to withdraw from the study without consequence. Focus group participants will be asked to provide their verbal consent twice: before the recording has begun and after to ensure consent is documented on
record.
Members of CDC and NNPHI project teams will lead the quantitative and qualitative analysis. Analysis will include descriptive characteristics of the study participants based on the quantitative data collected in the first part of the focus group. Descriptive statistics will be
computed from results of the demographic survey. Additional descriptive analyses will be performed as appropriate for the demographic data set.
Qualitative data will be imported into NVivo 11, a software program used to aid qualitative analysis. The software will facilitate analysis by organizing, classifying, and sorting data into categories and frequencies. The initial phase of qualitative analysis will involve transcript
review to identify categories, emergent themes, and to develop codes. CDC and NNPHI will work together to build an electronic codebook during this process. Open coding of larger segments of text will then commence. Axial coding will include assessment of possible
relationships between code groups. Descriptive subcodes and categories will be developed; codes may be restructured throughout the entire comparative analysis process until it is determined that saturation is attained. The codebook will be refined as needed during
this process. Members of the coding team will continually re-review, reconcile, and revise any discrepancies to ensure inter-coder consistency. Additional themes that are discovered through the process will also be analyzed and included in the findings.

13. Confidentiality protections:
Data will be reported in ways that protect the privacy of participants and comply with CDC’s Data Sharing Policy. Focus Groups will be recorded on two digital recorders -with the permission of the participants- and later transcribed by Brown & Meyers transcription service
based out of Scarborough, Maine. Two copies of the recording will be retained: one for NNPHI and one for Brown & Meyers. Recordings will shared with Brown & Meyers via a password protected account on a sharing site called ShareFile. ShareFile employs SSL/TLS
protocols to protect client authentication, authorization and file transfers, so security will be assured. Also, ShareFile protects files during storage by using SSAE 16 Type II accredited or ISO 27001 certified datacenters to host the SaaS application and metadata. All fles are
stored in SSAE 16 Type II (SOC1), SOC2 and ISO 27001 accredited datacenters with high availability and durability ratings.
ShareFile will be the only way in which Brown & Meyers is able to access the file. In addition, we will make a backup recording of all interviews using a digital recorder. The backup files, along with NNPHI’s copy of the digital recording will be kept on an external drive kept
in a locked office, in a locked filing cabinet. Any reference to a full name or other identifying information that arises unintentionally during the discussion will be redacted from the transcripts by NNPHI. Access to the encrypted transcript files will require a password and is
restricted to staff working on the project. Transcripts will be transferred between NNPHI and CDC using CDC’s External SharePoint site for partners, and stored on a firewall protected network drive at NNPHI.
Further detail about SharePoint is provided below:
CDC/NCHHSTP SharePoint is an online collaboration tool for securely managing and sharing information with staff and partner organizations. External partners access CDC SharePoint through CDC Join. CDC JOIN is a gateway for external partners to enter authorized
portions of CDC's secure environment. CDC JOIN provides external partners with the ability to collaborate with CDC by sharing password-protected, non-public information assets and electronic workspaces such as SharePoint.
CDC/NCHHSTP is responsible for its SharePoint content and ensuring shared information meets all security restrictions, such as protecting sensitive information and proper management of site content. As outlined in the HHS Information Security Privacy Policy memo,
CDC/NCHHSTP SharePoint users ensure that Personally Identifiable Information (PII) is appropriately collected, processed, stored and protected to maintain compliance with public laws, federal regulations and executive orders. These include the E-Government Act of
2002, the Health Insurance Portability and Accountability Act (HIPAA) of 1996, the Privacy Act of 1974, and related guidance established by the Office of Management and Budget (OMB).
In addition, NNPHI's Network drive is on a file server that is physically secure and locked with server closets. It is fully patched and up to date. The file Server is protected by a Firewall. Along with gateway security protection, antivirus software is running on the file server.
There is no unnecessary software installed on the file server and unnecessary services are stopped. There is NTFS security in use to restrict file and folder access to specific groups or individual users.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
Participants will be asked some questions that may be sensitive or uncomfortable and may trigger unpleasant feelings. Additionally, it is possible privacy
may be breached during recruitment, although recruitment support staff will be instructed to do everything they can ensure privacy during the recruitment
process such as not administering the screening tool in a public area.
The following steps will be taken to minimize the risk of breach of privacy during recruitment:
Schedule of Focus Groups. Focus group scheduling data will include: time and date of focus group, first name and first initial of last name and phone
number. This information will be kept separate from data collected (such as age, location, etc.). Schedules will not be linked to participant ID but will be
linked to the screener through first name and last initial until name on screener is removed by local partner staff and assigned an ID.

15. Projected time frame for the project:
05/01/2018-12/31/2018

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16. Plans for publication and dissemination of the project findings:
Results will be disseminated via a final report from NNHPI to CDC. All disseminated data will be
de-identified and stripped of personal identifying information. Research findings may also be
disseminated to the public in the form of manuscripts, abstracts, and presentations used for
submission for oral presentations at such conferences as the National STD Prevention
Conference, National HIV Prevention Conference, the American Public Health Association
Conference, and/or for peer-reviewed publications.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Appendix A Application for IRB review by Michigan Public Health Institute Office of Research
Integrity and Compliance
Appendix B Approval letter from MPHI ORIC
Appendix C Focus Group Guide
Appendix D Recruitment Flyers
Appendix E Eligibility Screener
Appendix F Consent Form

18. References (to indicate need and rationale for project):
References
1. Arnold EA and Bailey MM. (2009). Constructing Home and Family: How the Ballroom Community supports African-American GLBTQ Youth in the Face of HIV/AIDS. Journal of
Gay and Lesbian Social Services 21, 171-188.
2. Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2016. Atlanta: U.S. Department of Health and Human Services; 2017.
3. Goltz, B. (2015). We’re Not in Oz Anymore”: Shifting Generational Perspectives and Tensions of Gay Community, Identity, and Future, Journal of Homosexuality, 61:11,
1503-1528.
4. Holt, M. (2011). Gay men and ambivalence about ‘gay community’: from gay community attachment to personal communities, Culture, Health & Sexuality: An International Journal
for Research, Intervention and Care, 13:8, 857-871.
5. Maulsby C, Millett G, Lindsey K, Kelley R, Johnson K, Montoya D, Holtgrave D. (2014). HIV Among Black Men Who Have Sex with Men in the United States: A review of the
literature. AIDS Behavior 18:10-25
6. Ross, M. (2014). Gay Community Involvement: Its Interrelationships and Associations with Internet Use and HIV Risk Behaviors in Swedish Men Who Have Sex with Men, Journal
of Homosexuality, 61:2, 323-333.
7. Rowe M. (2008). Sex, love, friendship, belonging and place: Is there a role for ‘Gay Community’ in HIV prevention today? Culture, Health & Sexuality: An International Journal for
Research, Intervention and Care, 10:4, 329-344.
8. Wilson P, Valera P, Martos A, Wittlin N, Munoz-Laboy M, Parker R. (2016). Contributions of Qualitative Research in Informing HIV/AIDS Interventions Targeting Black MSM in the
United States. The Journal of Sex Research. 53:6, 642-654

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PROJECT APPROVAL
Choose one of the following options (Division or Center/OD Project)

DIVISION PROJECT

NCHHSTP BRANCH AND DIVISION ADS REVIEW AND APPROVAL (Sign electronically by clicking next to the X
and following the prompts)

X

Matthew S.
Hogben -S

Digitally signed by Matthew
S. Hogben -S
Date: 2018.04.16 13:00:29
-04'00'

Branch Chief or Branch Science Officer

X

Jami Leichliter
-S

Digitally signed by Jami
Leichliter -S
Date: 2018.04.18 13:52:50
-06'00'

Division ADS, Acting ADS, or Deputy ADS

CENTER/OD PROJECT

NCHHSTP OD OFFICE REVIEWS AND APPROVALS (Sign electronically by clicking next to the X and following
the prompts)

X

X

Office Associate Director or Designee

NCHHSTP ADS or Designee

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NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Project Engage 2.0: Engaging Gay Community Activism for Syphilis Prevention

Date received in NCHHSTP ADS or ADLS office:
Date received by NCHHSTP Deputy ADS or ADLS:
Select the checkbox for each applicable comment for Nos. 1–5 or select the checkbox for No. 6 if all of the comments apply.
Additional applicable comments may be added to No. 7. If additional information is required before approval can be
granted, select No. 8.

1. This project is approved by NCHHSTP/CDC and CDC (per CDC policies and federal regulations) for CDC staff
participation.
2. Participating partners and sites must obtain project review and approval, according to their institutional
policies and procedures and according to local, national, and international regulations and laws, including
45 CFR 46 regulations and state laws. CDC project officers must maintain a current copy of local sites’
approvals in project records.
3. CDC investigators and project officers need to adhere to the highest ethics standards of conduct and to
respect and protect the privacy, confidentiality, autonomy, data, welfare, and rights of participants and
integrity of the project. All applicable country, state, and federal laws and regulations must be followed.
4. Informed consent or script is needed as required by laws and regulations. Information conveyed in an
informed consent or script process needs to address all applicable required elements of informed consent.
Consent of employees in related projects about their institutions needs to include a statement that their
voluntary participation or withdrawal would not affect their employment status or opportunities.
5. OMB Paperwork Reduction Act determination by the NCHHSTP OMB/PRA Coordinator might be needed for
this project.
■

6. All previous comments apply.
7. Other applicable comments: Type your comment in the box. The space will expand as you type.

8. More information is required before approval is granted: Explain what additional information is requested by
typing in the box. The space will expand as you type.

Date Information was requested:
Date Information was received:

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Approval must be granted by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Associate
Director for Science (ADS), Acting ADS, or Deputy ADS, or for laboratory-associated projects, by the Associate
Director for Laboratory Science (ADLS) or Acting ADLS.

Project Title: Project Engage 2.0: Engaging Gay Community Activism for Syphilis Prevention

X

Alcia A.
Williams -S6

Digitally signed by Alcia A.
Williams -S6
Date: 2018.04.19 14:44:48
-04'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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